Provectus Biopharmaceuticals Completes Patient Accrual for PH-10 Phase 2 Clinical Study of Cellular & Immunologic Changes in ...
September 21 2015 - 6:00AM
Business Wire
Anticipated Completion Date December 2015 as
Projected
Provectus Biopharmaceuticals, Inc. (NYSE MKT:PVCT,
http://www.pvct.com), a clinical-stage oncology and dermatology
biopharmaceutical company (“Provectus” or the “Company”), today
announced that it has completed patient accrual for its phase 2
study of the cellular and immunologic changes in the skin of
patients receiving PH-10, an investigational topical treatment for
atopic dermatitis and psoriasis.
This phase 2 trial is a multicenter study of subjects with mild
to moderate psoriasis. Subjects apply PH-10 vehicle daily for 28
consecutive days followed by active PH-10 daily for 28 consecutive
days to their plaque psoriasis areas on the trunk or extremities
(excluding palms, soles, scalp, facial and intertriginous sites).
Biopsies of one target plaque are collected at baseline (at least 7
days prior to first study treatment on Day 1) and at Days 29 and
64, with a 7-day interval between biopsy at Day 29 and commencement
of application of active PH-10 on Day 36. Study data from each
subject will serve as an internal control (i.e., assessment at
baseline and at the end of application of PH-10 vehicle) for
assessment of clinical and cellular response to active
investigational agent.
Dr. Eric Wachter, CTO of Provectus, stated, “Given that the
patients remain on the study for a total of 92 days to monitor
their response to PH-10, Provectus anticipates that the originally
projected completion date of December 2015 will be the actual date
of completion for this 30 patient trial.”
Further information is available at
https://clinicaltrials.gov/ct2/show/record/NCT02322086.
About Provectus Biopharmaceuticals, Inc.
Provectus Biopharmaceuticals, Inc., specializes in developing
oncology and dermatology therapies. PV-10, its novel
investigational drug for cancer, is designed for injection into
solid tumors (intralesional administration), thereby reducing
potential for systemic side effects. Its oncology focus is on
melanoma, breast cancer and cancers of the liver. The Company has
received orphan drug designations from the FDA for its melanoma and
hepatocellular carcinoma indications. PH-10, its topical
investigational drug for dermatology, is undergoing clinical
testing for psoriasis and atopic dermatitis. Provectus has
completed phase 2 trials of PV-10 as a therapy for metastatic
melanoma, and of PH-10 as a topical treatment for atopic dermatitis
and psoriasis. Information about these and the Company’s other
clinical trials, including its current phase 3 study in melanoma,
can be found at the NIH registry, www.clinicaltrials.gov.
For additional information about Provectus, please visit the
Company’s website at www.pvct.com or contact Porter, LeVay &
Rose, Inc.
FORWARD-LOOKING STATEMENTS: This release contains
"forward-looking statements" as defined under U.S. federal
securities laws. These statements reflect management's current
knowledge, assumptions, beliefs, estimates, and expectations and
express management's current views of future performance, results,
and trends and may be identified by their use of terms such as
"anticipate," "believe," "could," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "will," and other similar
terms. Forward-looking statements are subject to a number of risks
and uncertainties that could cause our actual results to materially
differ from those described in the forward-looking statements.
Readers should not place undue reliance on forward-looking
statements. Such statements are made as of the date hereof, and we
undertake no obligation to update such statements after this
date.
Risks and uncertainties that could cause our actual results to
materially differ from those described in forward-looking
statements include those discussed in our filings with the
Securities and Exchange Commission (including those described in
Item 1A of our Annual Report on Form 10-K for the year ended
December 31, 2014) and the following:
- our determination, based on guidance
from the FDA, whether to proceed with or without a partner with the
fully enrolled phase 3 trial of PV-10 to treat locally advanced
cutaneous melanoma and the costs associated with such a trial if it
is necessary to complete (versus interim data alone);
- our determination whether to license
PV-10, our melanoma drug product candidate, and other solid tumors
such as cancers of the liver, if such licensure is appropriate
considering the timing and structure of such a license, or to
commercialize PV-10 on our own to treat melanoma and other solid
tumors such as cancers of the liver;
- our ability to license our dermatology
drug product candidate, PH-10, on the basis of our phase 2 atopic
dermatitis and psoriasis results, which are in the process of being
further developed in conjunction with mechanism of action studies;
and
- our ability to raise additional capital
if we determine to commercialize PV-10 and/or PH-10 on our own,
although our expectation is to be acquired by a prospective
pharmaceutical or biotech concern prior to commercialization.
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version on businesswire.com: http://www.businesswire.com/news/home/20150921005169/en/
Provectus Biopharmaceuticals, Inc.Peter R. Culpepper,
866-594-5999 #30CFO, COOorPorter, LeVay & Rose, Inc.Investor
RelationsMarlon Nurse, 212-564-4700DM, SVPorMedia RelationsTodd
Aydelotte, 646-428-0644
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